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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K942674
Device Name ANGIOREST TABLE PAD SYSTEM
Applicant
Scribner Browne Medical Design, Inc.
5589 Arapahoe, #207
Boulder,  CO  80303
Applicant Contact ROBERT M SCRIBNER
Correspondent
Scribner Browne Medical Design, Inc.
5589 Arapahoe, #207
Boulder,  CO  80303
Correspondent Contact ROBERT M SCRIBNER
Regulation Number892.1650
Classification Product Code
JAA  
Date Received06/06/1994
Decision Date 07/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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